AOAC SPIFAN Review Team Meeting Book-July 22, 2015

BVIT-01 (SLV) FOR ERP/WORKING GROUP USE ONLY DO NOT DISTRIBUTE

Method Validation Report

41 of 49

Version

1

Page

Validation Report for the Determination of Thiamin HCl, Riboflavin, Niacin (Nicotinic Acid and Nicotinamide), Pantothenic acid, Vitamin B6 (Pyridoxine, Pyridoxal and Pyridoxamine) and Biotin in Infant Formula and Adult Nutritionals by LC-MS/MS

Document Title

Table 42: Accuracy of Nicotinic acid in Partially hydrolyzed protein infant formula powder

Nicotinic acid (mcg/100g)

Un- spiked Result

Resulting Spiked Conc

Spiked Result

% Recovery

Acceptable

Over Spike

Theoretical Spiked Conc (C)

Replicates

(A)

(B)

(A+C)

B/(A+C)

Y/N

Replicate 1 197.55

Mean

Replicate 2 213.29

204.96

0%

Replicate 3 204.05

Replicate 1

312.76

291.82

86.86

107.18

Y

Replicate 2

314.14

291.82

86.86

107.65

Y

50%

Replicate 3

314.42

291.82

86.86

107.74

Y

Replicate 1

411.72

378.67

173.71

108.73

Y

Replicate 2

408.18

378.67

173.71

107.79

Y

100%

Replicate 3

401.08

378.67

173.71

105.92

Y

Acceptance Criteria: All individual recovery results should be within 90 % to 110 %.

Page 54